GSK has agreed to waive royalties on the basis that Apotex’s triple combination generic ARV will be supplied on a no profit basis. The drug contains two molecules over which GSK has patent rights (zidovudine and lamivudine), which are used in the company’s combination pill Combivir.
The initiative is part of Canada’s Access to Medicines Regime, which enables the government to authorize the production of certain patented medicines for export. The legislation includes controls which are designed to ensure that these essential medicines reach the patients for whom they are intended and the authorization to be granted will be subject to these controls.
Paul Lucas, president and CEO, GSK Canada, said: “Tackling the AIDS crisis is one of the greatest challenges the world faces. GSK continues to play its part to tackle this crisis through R&D, not-for-profit pricing and ongoing investment in dedicated community programs. Our decision to allow Apotex to manufacture an FDC containing two GSK molecules is part of this broad commitment.”